Treatment of Coronary In-Stent Restenosis (TIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University Hospital Ostrava
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT01735825
First received: November 7, 2012
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus.


Condition Intervention Phase
Restenosis
Device: paclitaxel-coated balloon catheter
Device: drug eluting stent with everolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Drug Eluting Paclitaxel-coated Balloon and Drug Eluting Stent With Everolimus.

Resource links provided by NLM:


Further study details as provided by University Hospital Ostrava:

Primary Outcome Measures:
  • Late lumen loss [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Late loss was defined as the minimal vessel lumen diameter immediately after the procedure minus the lumen diameter at angiographic follow-up


Secondary Outcome Measures:
  • Major Adverse Cardiac Events [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    Major Adverse Cardiac Events are defined as cardiovascular death, acute myocardial infarction or target vessel revascularisation


Other Outcome Measures:
  • Binary restenosis [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Binary restenosis is defined as a > 50% diameter stenosis at angiographic follow-up.


Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paclitaxel-coated balloon
Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter
Device: paclitaxel-coated balloon catheter
Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter
Active Comparator: drug eluting stent
Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus
Device: drug eluting stent with everolimus
Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus

Detailed Description:

In-stent restenosis after coronary angioplasty is currently one of the main limitations of this method, leading to a recurrence of exertional angina pectoris or manifesting as acute coronary syndrome. Histopathologic substrate of in-stent restenosis is neointimal hyperplasia.

Repeated plain balloon angioplasty or using cutting balloon catheters in the treatment of in-stent restenosis does not achieve satisfactory results. Brachytherapy, used in the past, it has also abandoned. The current treatment of in-stent restenosis is the use of drug eluting stents. Local drug released from these stents prevents new neointimal hyperplasia.This treatment carries the risk of late thrombosis (due to delayed neoendotelization) the stent struts and requires rigorous long-term dual antiplatelet therapy with the risk of bleeding complications. The drug-coated balloon catheters provide short-term penetration of the active substance into the vascular wall, leading to the inhibition of hyperproliferation vascular smooth muscle cells, but due to short-term effect they do not affect negatively stent struts neoendotelization. Comparable effects of in-stent restenosis therapy using paclitaxel releasing balloons was demonstrated in comparison with paclitaxel releasing stents, however, the development of drug eluting stents meanwhile progressed. The aim of our study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus. Primary endpoint of our study is late lumen loss, because it represents accurate angiographic parameter predicting the need for repeat revascularisation and thus the clinical benefit for the patient.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • history of percutaneous coronary intervention with stent placement
  • verified coronary in-stent restenosis suitable for percutaneous re-intervention
  • signed informed consent

Exclusion Criteria:

  • contraindication to long term dual antiplatelet therapy
  • increased risk of bleeding
  • known generalized malignancy
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735825

Locations
Czech Republic
University Hospital Recruiting
Ostrava, Czech Republic, 708 52
Contact: Jiri Hyncica, Bc.    +420597372510    jiri.hyncica@fno.cz   
Principal Investigator: Leos Pleva, M.D.         
Sponsors and Collaborators
University Hospital Ostrava
Investigators
Principal Investigator: Leos Pleva, M.D. Cardiovascular Department, University Hospital Ostrava, Czech Republic
  More Information

No publications provided

Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01735825     History of Changes
Other Study ID Numbers: FNO-KVO 631/2011 Pleva
Study First Received: November 7, 2012
Last Updated: December 30, 2013
Health Authority: Czech Republic: Ethics Committee

Keywords provided by University Hospital Ostrava:
coronary artery disease
stent
restenosis

Additional relevant MeSH terms:
Everolimus
Sirolimus
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014